Medical devices that are placed on the market in the European Union have to possess a CE marking, which indicates that a product complies with legal requirements effective in the EU and that all conformity assessment procedures have been completed. Producers of medical devices are responsible for providing the compliance with the regulations presented below no matter whether they commission a part of or a whole production.
Obligations of medical devices producents resulting from new European Union’s regulations - MDR and IVDR
On 26th of May 2020 a transitional period expires. It has been effective since May 2017 when the new EU regulations concerning medical devices were published:
- MDR (Medical Device Directive) - a regulation concerning the production of medical devices.
- IVDR (In Vitro Diagnostic Regulation) – a regulation concerning the production of medical devices used for in vitro diagnostics.
- The adoption of those regulations entails repealing of the directives 93/42/EWG (MDD) and 90/385/EWG (AAIMDD) that are currently being in force. The devices that possess the certificates of conformity issued on the basis of the MDD/AAIMDD directives can be marketed until 27th May 2024.
According to the new regulations the producers of medical devices are obliged to, i. a.:
- possess quality management systems and risk management systems,
- possess systems enabling marking devices with unique identification codes (UDI),
- prepare technical documentation,
- apply conformity assessment procedures,
- conduct clinical evaluation,
- possess systems enabling supervision after marketing a product.
If you cooperate with an electronics manufacturing services provider, verify if your contractor is prepared for the changes mentioned above and capable supporting you in fulfilling part of the obligations resulting from those regulations.
Key production standards in the medical industry
There are 4 key ISO standards that enable one to complete the requirements included in the EU’s MDR and IVDR regulations (in Assel we operate according to every of the following norms – you can find more about it on our medical industry market.
- quality management system for medical devices ISO 13485
- quality management system ISO 9001
- environmental management system ISO 14001
- continuity management system ISO 22301
ISO 13485 - (Medical devices - Quality management systems - Requirements for regulatory purposes) – a quality management system for medical devices prepared in accordance with the requirements of the ISO 9001 system, but broadening and specifying those requirements. It has been designed specifically for the producers of medical devices. The compliance with ISO 13485 indicates that we have implemented and maintained general inspection procedures for quality, traceability and validation as well as risk management procedures.
ISO 14001 – an environmental management system prepared for the producers who aim at operating according to the Lean methodology. The fact that we hold this certification indicates that we have implemented and maintained procedures for the minimisation of the amount of waste and used resources. As a result, we have been able to save energy and reduce a general carbon footprint. This is especially important in terms of complex supply chains.
ISO 22301– a business continuity management system standard indicates that we have implemented and maintained hazard and risk identification procedures as well as introduced proper protection measures. Also, it proves that we are capable of efficient responding to any emergencies.
In addition, to achieve the highest possible standards of realisation, the assembly of complex electronic systems in Assel is performed according to an IPC-A-610 (class 2 and 3) norm.
Production in accordance with the MDR and IVDR requirements.
The certificates and norms that we possess as well as a team of experienced employees enable us to provide:
- full traceability thanks to a modern software, automatic laser marking systems and labels marking,
- traceability, validation and risk management procedures resulting from the implementation and maintenance of the ISO standards,
- active support in the process of obtaining certifications for products (e.g. CCC/Intertek/TUV) as well as preparation of documentation for the notified bodies.